COUGH RELIEF- dextromethorphan hydrobromide capsule, liquid filled 
Advanced Rx LLC

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Cough Relief

Drug Facts

Active Ingredient (in each tablet)

Dextromethorphan HBr, USP 15 mg

Purpose

Cough suppressant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Warnings

Do not useif you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• a cough that occurs with too much phlegm (mucus)

• a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

 adults and children 12 years and older take 2 softgels every 6 to 8 hours, as needed
 children under 12 years do not use

Other information

• store between  20° and 25°C (68°–77°F)

• avoid excessive heat above 40°C (104°F)

• protect from light

• DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive ingredients

Edible Ink, FD&C Red No. 40, Gelatin, Glycerin, Polyethylene Glycol 400, POLYSORB, Propylene Glycol, Purified Water, Povidone K30.

Questions?

Call  1-800-630-8895

Distributed by: 

Advanced Rx LLC

1942 NE 163rd St

North Miami Beach,

FL 33162 U.S.A.

NDC 80513-311-06

Cough Relief

LABEL

COUGH RELIEF 
dextromethorphan hydrobromide capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80513-311
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE K30 (UNII: U725QWY32X)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize13mm
FlavorImprint Code 904
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80513-311-0660 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/01/2025
Labeler - Advanced Rx LLC (042795108)
Establishment
NameAddressID/FEIBusiness Operations
ELYSIUM PHARMACEUTICALS LIMITED915664486manufacture(80513-311)

Revised: 1/2025
Document Id: 2bd504ed-3944-e6ce-e063-6294a90aa3de
Set id: 297e10e3-e740-4434-91a2-2e5c54985d33
Version: 1
Effective Time: 20250101
 
Advanced Rx LLC